Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865874
Status:
UNKNOWN
Last Update Posted:
2022-10-10
First Post:
2021-04-14
Brief Title:
GDT-PPV Protocol in Thoracic Surgery
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Advantages of Pulse Pressure Variation PPV Monitoring in Thoracic Surgery
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Peri-operative fluid-therapy is extremely important in thoracic surgery because excessive administration of fluids during one-lung ventilation is correlated to an increasing risk of postoperative respiratory complications
Therefore current guidelines on peri-operative management of patients undergoing thoracic surgery suggest a conservative fluid management strategy based on intra-operative fluid loss replacement and maintenance of euvolemia
Nevertheless intra-operative fluid loss estimation and consequently the correct infusion rate adoption are quite difficult to be addressed in clinical practice and this often prevents the euvolemia maintenance in the peri-operative period
This limit claims the necessity to adopt new methods of fluid-therapy administration in thoracic surgery among these the most promising is the Goal-Directed Therapy GDT GDT protocols based on Stroke Volume Variation SVV or Pulse Pressure Variation PPV monitoring have been adopted successfully in major and cardiac surgery but not yet in thoracic surgery
The aim of this randomized study is to evaluate the effects of a PPV-GDT fluid management protocol versus a conservative zero-balance protocol on intrapulmonary gas exchanges in patients undergoing single-lung ventilation during thoracic surgery
Therefore current guidelines on peri-operative management of patients undergoing thoracic surgery suggest a conservative fluid management strategy based on intra-operative fluid loss replacement and maintenance of euvolemia
Nevertheless intra-operative fluid loss estimation and consequently the correct infusion rate adoption are quite difficult to be addressed in clinical practice and this often prevents the euvolemia maintenance in the peri-operative period
This limit claims the necessity to adopt new methods of fluid-therapy administration in thoracic surgery among these the most promising is the Goal-Directed Therapy GDT GDT protocols based on Stroke Volume Variation SVV or Pulse Pressure Variation PPV monitoring have been adopted successfully in major and cardiac surgery but not yet in thoracic surgery
The aim of this randomized study is to evaluate the effects of a PPV-GDT fluid management protocol versus a conservative zero-balance protocol on intrapulmonary gas exchanges in patients undergoing single-lung ventilation during thoracic surgery
Detailed Description:
The intra-operative fluid-therapy using lactated Ringer will be based on pulse pressure variation PPV group with a target 58 or on compensation 11 of urine output zero balance group
In both groups an intraoperative background infusion of lactated Ringer at 1-2 mlkgh will be administered
In both groups an intraoperative background infusion of lactated Ringer at 1-2 mlkgh will be administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None